Brand Name | PIPELINE FLEX W/SHIELD TECHNOLOGY |
Type of Device | INTRACRANIAL ANEURYSM FLOW DIVERTER |
Manufacturer (Section D) |
MICRO THERAPEUTICS, INC. DBA EV3 |
9775 toledo way |
irvine CA 92618 |
|
Manufacturer (Section G) |
MICRO THERAPEUTICS, INC. DBA EV3 |
9775 toledo way |
|
irvine CA 92618 |
|
Manufacturer Contact |
david
gustafson
|
9775 toledo way |
irvine, CA 92618
|
7635149628
|
|
MDR Report Key | 12355989 |
MDR Text Key | 267746626 |
Report Number | 2029214-2021-01049 |
Device Sequence Number | 1 |
Product Code |
OUT
|
Combination Product (y/n) | N |
Reporter Country Code | FR |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
08/23/2021 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 08/23/2021 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 07/30/2022 |
Device Model Number | PED2-400-10 |
Device Catalogue Number | PED2-400-10 |
Device Lot Number | A874062 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 08/17/2021 |
Date Device Manufactured | 07/31/2019 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Hospitalization;
|
Patient Age | 35 YR |